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: Introduction: A Programme Science approach that prioritizes populations who will benefit most and ensuring resources are allocated to programmes that meet the needs of those populations will bring an equity focus to research. Gay men and other men who have sex with men, people who use drugs, sex workers of all genders, and trans and gender‐diverse people, defined by the Joint United Nations Programme on HIV/AIDS (UNAIDS) and The Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) as key populations, have been disproportionately impacted since the start of the HIV pandemic. Through documenting community experiences from global key population‐led networks, the authors explore the potential value and impact of community‐led organizations and service delivery as critical components in effective HIV and Sexually Transmitted infections (STI) programmes. Discussion: Through advocacy and research interventions, global key population networks have identified barriers against scaling up interventions for criminalized and marginalized communities, as well as highlighted solutions. The authors examine some of the current barriers to meaningful involvement of communities and the scaling up of community‐led programmes that need to be addressed if Programme Science is to maintain an equity lens and the needs of key populations are to be met and highlight the need to make visible community engagement and participation in embedded research and Programme Science. Conclusions: The Programme Science approach provides an important opportunity to understand practical issues that will increase effective coverage in the implementation of public health and other interventions, which will require the prioritizing of key populations and their priorities in HIV and STI programmes. It will require extensive time and work to build relationships, increase capacity and share power. Where this has already happened, it has resulted in positive outcomes, including better health outcomes, reduced stigma, increased agency for key populations, and built community‐led organizations and responses., INTRODUCTION A Programme Science approach that prioritizes populations who are most vulnerable to poor health outcomes will bring an equity focus to Programme Science and research and ensure resources are [...]

UNLABELLED: Obstructive sleep apnea (OSA) may lead to serious health, safety, and financial implications-including sleepiness-related crashes and incidents-in workers who perform safety-sensitive functions in the transportation industry. Evidence and expert consensus support its identification and treatment in high-risk commercial operators. An Advanced Notice of Proposed Rulemaking regarding the diagnosis and treatment of OSA in commercial truck and rail operators was issued by the Federal Motor Carrier Safety Administration and Federal Railroad Administration, but it was later withdrawn. This reversal has led to questions about whether efforts to identify and treat OSA are warranted. In the absence of clear directives, we urge key stakeholders, including clinicians and patients, to engage in a collaborative approach to address OSA by following, at a minimum, the 2016 guidelines issued by a Medical Review Board of the Federal Motor Carrier Safety Administration, alone or in combination with 2006 guidance by a joint task force. The current standard of care demands action to mitigate the serious health and safety risks of OSA. CITATION: Das AM, Chang JL, Berneking M, et al. Enhancing public health and safety by diagnosing and treating obstructive sleep apnea in the transportation industry: an American Academy of Sleep Medicine position statement. J Clin Sleep Med. 2022;18(10):2467-2470.

Purpose Thecurrent manuscript explores barriers to care for pregnant and post-partum women experiencing co-occurring intimate partner violence and opioid use disorder through the lens of providers who work with this unique population. Methods We conducted a qualitative study consisting of 49 semi-structured, open-ended interviews with service providers working across contexts (e.g., IPV, prenatal care, substance use, addiction medicine, law enforcement, criminal justice, welfare services, etc.). Results Participants reported three main types of barriers which can impact outcomes and reduce care for pregnant and post-partum women with co-occurring IPV and OUD (Co-IPV/OUD). 1) Barriers that make it difficult for pregnant or post-partum women to seek, receive, and successfully engage in care for both IPV and OUD. Barriers that providers encounter in trying to care for and/or treat pregnant and post-partum women with Co-IPV/OUD. Lastly, barriers which present a challenge to providing comprehensive, coordinated care for pregnant or post-partum women with Co-IPV/OUD. Conclusion We conclude that finding ways to improve coordinated or integrated care for IPV and OUD is vital to outcomes for this population, and initiatives which support providers' ability to work across different service contexts are needed., Author(s): Penelope K. Morrison [sup.1] , Emily Yourish [sup.2] , Judy C. Chang [sup.3] , Elizabeth Krans [sup.3] , Chelsea Pallatino-Trevelline [sup.4] Author Affiliations: (1) grid.29857.31, 0000 0001 2097 4281, [...]

BackgroundPostpartum contraception counseling and method use vary widely among patients who had a preterm birth. We performed this study to explore what issues and concerns individuals with preterm infants requiring intensive care describe as influencing their postpartum contraceptive choices.MethodsWe conducted a qualitative study using semi-structured interviews with participants who gave birth to a singleton preterm infant admitted to the neonatal intensive care unit (NICU). We explored pregnancy, childbirth, postpartum care, and NICU experiences, as well as future reproductive plans and postpartum contraceptive choices. Two coders used a constant-comparative approach to code transcripts and identify themes.ResultsWe interviewed 26 participants: 4 (15%) gave birth at less than 26, 6 (23%) at 26 to 27 6/7, 8 (31%) at 28 to 31 6/7, and 8 (31%) at 32 to 36 6/7 weeks of gestation. We identified three main themes related to future pregnancy plans and contraception choice. First, participants frequently described their preterm birth and their infants' NICU hospitalization as traumatic experiences that affected plans for future pregnancies. The loss of control in predicting or preventing a future preterm birth and uncertainty about their premature child's future medical needs resulted in participants wanting to avoid going through the same experience with another child. Second, participants chose contraception based on previous personal experiences, desired method features, and advice from others. Last, having a preterm birth did not result in any ambivalence among those who desired permanent contraception.ConclusionsPreterm birth influences future pregnancy plans. When discussing reproductive goals with patients, clinicians should be aware of potential trauma associated with a premature birth, assess for whether patients want to discuss contraception, and center the conversation around individual needs if patients do desire contraceptive counseling.

Limited research has been done among pregnant people participating in investigational drug trials. To enhance the ethical understanding of pregnant people's perspectives on research participation, we sought to describe motives and risk perceptions of participants in a phase 1 trial of ledipasvir/sofosbuvir (LDV/SOF) treatment for chronic Hepatitis C virus (HCV) during pregnancy. Pregnant people with chronic HCV infection enrolled in an open-label, phase 1 study of LDV/SOF participated in semi-structured, in-depth interviews to explore their reasons for participation and experiences within the study. Pregnant people took 12 weeks of LDV/SOF and were interviewed at enrollment and at the end of study. We recorded the interviews, transcribed them verbatim, coded them using NVivo software, and performed inductive thematic analysis. Nine women completed the study yielding 18 interview transcripts. We identified two themes regarding motives and one regarding risk perception. Motives--(1) Women conceptualized study participation as part of the caregiving role they associate with motherhood; participating was viewed as an act of caregiving for their infants, their families, themselves, and other pregnant women with chronic HCV. (2) Women also noted that they faced multiple barriers to treatment prior to pregnancy that created a desire to receive therapy through trial participation. Risk perception--(3) Women acknowledged personal and fetal risk associated with participation. Acceptance of risk was influenced by women's concepts of motherhood, preexisting knowledge of HCV and medical research, family members, intimate partners, or by the study design. Women enrolled in a phase 1 trial for chronic HCV therapy during pregnancy acknowledged risks of participation and were motivated by hopes for fetal and personal benefit and by lack of prenatal access to treatment. Ethical inclusion of pregnant people in research should acknowledge structural factors that contribute to vulnerability and data deficiencies for treatment in pregnancy.

IntroductionKey populations at elevated risk to contract or transmit HIV may also be at higher risk of COVID-19 complications and adverse outcomes associated with public health prevention measures. However, the conditions faced by specific populations vary according to social, structural and environmental factors, including stigma and discrimination, criminalization, social and economic safety nets and the local epidemiology of HIV and COVID-19, which determine risk of exposure and vulnerability to adverse health outcomes, as well as the ability to comply with measures such as physical distancing. This commentary identifies common vulnerabilities and cross-cutting themes in terms of the impacts of COVID-19 on key populations before addressing issues and concerns specific to particular populations.DiscussionCross-cutting themes include direct impacts such as disrupted access to essential medicines, commodities and services such as anti-retroviral treatment, HIV pre-exposure prophylaxis, opioid agonist treatment, viral load monitoring, HIV and sexually transmitted infections testing, condoms and syringes. Indirect impacts include significant collateral damage arising from prevention measures which restrict human rights, increase or impose criminal penalties, and expand police powers to target vulnerable and criminalized populations. Significant heterogeneity in the COVID-19 pandemic, the underlying HIV epidemic and the ability of key populations to protect themselves means that people who inject drugs and sex workers face particular challenges, including indirect impacts as a result of police targeting, loss of income and sometimes both. Geographical variations mean that transgender people and men who have sex with men in regions like Africa and the middle east remain criminalized, as well as stigmatized and discriminated against, increasing their vulnerability to adverse outcomes in relation to COVID-19.ConclusionsDisruptions to both licit and illicit supply chains, loss of income and livelihoods and changes in behaviour as a result of lockdowns and physical distancing have the potential to exacerbate the impacts of the COVID-19 pandemic on key populations. While these impacts will vary significantly, human-rights approaches to COVID-19 emergency laws and public health prevention measures that are population-specific and sensitive, will be key to reducing adverse health outcomes and ensuring that no one is left behind.

INTRODUCTION:: Postpartum care can be fragmented, especially among women with premature infants in the Neonatal Intensive Care Unit (NICU). We aimed to explore women's goals for and experiences with postpartum care. METHODS:: We conducted a qualitative study using semi-structured interviews to ask women between 2 and 8 weeks after delivery of preterm infants in the NICU about their preferred topics of discussion at the postpartum visit and experiences with postpartum care. We analyzed transcripts using thematic analysis. IRB approval obtained. RESULTS:: We enrolled 16 mothers who delivered between 25 and 34 weeks gestation (11 by Cesarean). At interview time (14-55 days postpartum), 4 women had attended a postpartum visit, 2 had missed their visit, and 10 had an upcoming appointment scheduled. Reasons for not attending a visit included distance of clinic from NICU, a desire to focus on their infant's health, and insurance changes. Participants identified several topics of importance for postpartum visits: assessing physical recovery after delivery (e.g., incision care, management of ongoing medical conditions), lactation support, and implications of preterm delivery for future pregnancies. One theme women described was feeling traumatized by the delivery or NICU experience and expressing concern about postpartum depression or anxiety. Participants suggested scheduling a visit soon after delivery (e.g., within 3 weeks postpartum) to assess mood. CONCLUSION:: Women with premature infants requiring NICU hospitalization are at risk for delayed or inadequate postpartum care given concern for their infants' health. Arranging short-term follow-up after delivery allows clinicians to perform early assessments and offer anticipatory guidance for postpartum depression.

Research on intimate partner violence shows that individuals who employ abusive behaviors also often have other psychosocial health problems (e.g., substance use) that may limit their ability to engage in treatment for abuse. Limited information exists regarding the psychosocial health needs of individuals who perpetrate abuse and how those needs play a role in their ability to follow through and complete an intervention program. Administrative data from one batterer intervention program (BIP) (N = 330), the local Department of Human Services, and court records were used to explore the relationship of service involvement to post-BIP recidivism. We found that over half the sample had engagement with DHS prior to starting the BIP, and general welfare, health and medical assistance, and behavioral health services were the most accessed programs. Additionally, recidivism for any crime was significantly higher among those with prior DHS involvement. Individuals who perpetrate abuse and who have a history of contact with DHS may represent the most vulnerable population with regards to both risk for attrition from a BIP and future recidivism. Future studies should seek to understand best practices for referrals and coordinated care for individuals who perpetrate abuse and ensure access to a broad range of services to help assist in reducing violent behaviors., Author(s): Penelope K. Morrison [sup.1] , Kelley Jones [sup.2] , Elizabeth Miller [sup.3] , Patricia A. Cluss [sup.4] , Donna George [sup.5] , Rhonda Fleming [sup.6] , Judy C. Chang [...]

The world is not on track to reach the majority of the UNAIDS 2025 targets, and people who inject drugs (PWID) continue to be left behind, hindered by counterproductive law enforcement practices, punitive laws, economic distress, and social stigma and discrimination. Poor access to HIV pre-exposure prophylaxis (PrEP) among PWID is nested within the limited access to broader harm reduction services, including needle and syringe programs, opioid overdose management, opioid agonist therapy (also known as medication-assisted treatment), and condoms. Among PWID, women who inject drugs are disproportionately affected and face additional gender-based barriers. Intersections between PWID and other key and priority population groups also exist. Although the prioritization of PWID for new PrEP products like the dapivirine vaginal ring and injectable cabotegravir has lagged in research, studies have shown that PWID find injectable and long-acting options acceptable and preferrable, including among women who inject drugs. While new PrEP products introduce new opportunities, equity in access must be assured for optimized impact toward achieving epidemic control. Programming for services must engage and empower PWID community leadership to address the structural barriers to services, implement community-led, differentiated, and integrated service modalities, and offer the choice of all harm reduction options to close the equity gaps in health outcomes. While waiting for necessary evidence and approvals, programs should work together with the PWID community to prioritize, expand, and facilitate efforts and investments toward increased access to and integration of PrEP and all recommended harm reduction services for PWID. [ABSTRACT FROM AUTHOR]

Introduction: Economic abuse is one form of intimate partner violence (IPV) intended to control a survivor's ability to make, save, or spend money to gain power over them. Perinatal people may be more vulnerable to economic abuse due to changes in employment and finances. This study's aims were to explore how economic abuse manifests among pregnant and parenting survivors and how best to support pregnant and parenting survivors of economic abuse. Methods: We conducted virtual semistructured interviews with IPV survivors and IPV advocates. Participants were recruited through an online recruitment registry, national IPV organizations, and local domestic violence agencies. Interview audiorecordings were transcribed. We used a deductive–inductive thematic analysis approach. Two research team members individually coded each transcript and met to resolve discrepancies in coding. Results: We completed interviews with 18 advocates and 20 survivors. Participants described experiences of financial control, exploitation, and employment sabotage. Partners leveraged the criminal–legal, child welfare, and health care systems and cultural norms about pregnancy, including those related to gender and religion to financially harm survivors. Advocates described how economic abuse impacts marginalized survivors. Dream resources described include cash assistance, healthy relationship and financial education, and employer policies. Discussion: Survivors and advocates reported a variety of experiences with economic abuse during the perinatal period. Future interventions should focus on providing unrestricted cash transfers to survivors, developing education on economic abuse, and creating supportive policies in health care and employment settings. This study highlights the ways that economic abuse specifically impacts perinatal survivors and their children. [ABSTRACT FROM AUTHOR]

To explore pediatricians' perspectives on supporting intimate partner violence (IPV) survivors, including (a) clinical practices and resource use, (b) ideal resources, and (c) barriers to the use of existing resources, we conducted dyadic and individual virtual interviews with pediatricians recruited through Twitter and the American Academy of Pediatrics Council, section, and chapter listservs. The interviews were approximately 60 minutes in length, audio recorded, and transcribed verbatim. We used a thematic analysis approach and hybrid deductive–inductive coding. Twenty-three pediatricians participated in 14 interviews. We identified four themes. Participants' current practices primarily focused on IPV screening and response to disclosure. They described strategies for IPV resource provision and decision-making involving child protective services. They identified multilevel barriers to addressing IPV, including barriers, such as time, identified in previous studies as well as barriers related to the COVID-19 pandemic, telehealth, the electronic health record, and disclosure-focused approaches. The participants desired provider-facing and caregiver-facing resources to strengthen the capacity to address IPV; some were unaware of currently available resources. They noted the need for continued attention to optimizing systems to enhance their capacity to support IPV survivors. Pediatricians report varying practices to address IPV and identify several surmountable barriers to supporting IPV survivors. Our study suggests that disclosure-driven clinical practices, confidentiality concerns, and lack of resources limit pediatricians' capacity to address IPV. Additional resource development and dissemination efforts are needed to improve the awareness of IPV resources currently available to pediatricians and families. [ABSTRACT FROM AUTHOR]

The 2016 World Health Organization (WHO) 2030 global elimination targets for hepatitis C virus (HCV) are: 80% of those with chronic HCV treated, 90% reduction in incidence and 65% reduction [...]

Fibroblasts can be transdifferentiated directly into other somatic cells such as cardiomyocytes, hematopoietic cells, and neurons. An advantage of somatic cell differentiation without first generating induced pluripotent stem cells (iPSCs) is that it avoids contamination of the differentiated cells with residual iPSCs, which may cause teratoma. However, since primary fibroblasts from biopsy undergo senescence during repeated culture, it may be difficult to grow transdifferentiated cells in sufficient numbers for future therapeutic purposes. To circumvent this problem, we reversibly immortalized primary fibroblasts by using the piggyBac transposon to deliver the human telomerase reverse transcriptase (hTERT) gene hTERT plus SV40 Large T. Both approaches enabled fibroblasts to grow continuously without senescence, and neither caused teratoma formation in immunodeficient mice. However, fibroblasts immortalized with hTERT plus SV40 large T antigen accumulated chromosomal rearrangements, whereas fibroblasts immortalized with hTERT retained the normal karyotype. To transdifferentiate hTERT-immortalized fibroblasts into other somatic lineage cells, we transiently transfected them with episomal OCT4 and cultured them under neural cell growth condition with transposase to remove the transposon. Tripotent neural progenitor cells were seamlessly and efficiently generated. Thus, reversible immortalization of primary fibroblasts with hTERT will allow potential autologous cell-based therapeutics that bypass and simulate iPSC generation.

Cystic fibrosis (CF) is a recessive inherited disease associated with multiorgan damage that compromises epithelial and inflammatory cell function. Induced pluripotent stem cells (iPSCs) have significantly advanced the potential of developing a personalized cell-based therapy for diseases like CF by generating patient-specific stem cells that can be differentiated into cells that repair tissues damaged by disease pathology. The F508del mutation in airway epithelial cell-derived CF-iPSCs was corrected with small/short DNA fragments (SDFs) and sequence-specific TALENs. An allele-specific PCR, cyclic enrichment strategy gave ~100-fold enrichment of the corrected CF-iPSCs after six enrichment cycles that facilitated isolation of corrected clones. The seamless SDF-based gene modification strategy used to correct the CF-iPSCs resulted in pluripotent cells that, when differentiated into endoderm/airway-like epithelial cells showed wild-type (wt) airway epithelial cell cAMP-dependent Cl ion transport or showed the appropriate cell-type characteristics when differentiated along mesoderm/hematopoietic inflammatory cell lineage pathways.

β-thalassemia, one of the most common genetic diseases worldwide, is caused by mutations in the human hemoglobin beta (HBB) gene. Creation of human induced pluripotent stem cells (iPSCs) from β-thalassemia patients could offer an approach to cure this disease. Correction of the disease-causing mutations in iPSCs could restore normal function and provide a rich source of cells for transplantation. In this study, we used the latest gene-editing tool, CRISPR/Cas9 technology, combined with the piggyBac transposon to efficiently correct the HBB mutations in patient-derived iPSCs without leaving any residual footprint. No off-target effects were detected in the corrected iPSCs, and the cells retain full pluripotency and exhibit normal karyotypes. When differentiated into erythroblasts using a monolayer culture, gene-corrected iPSCs restored expression of HBB compared to the parental iPSCs line. Our study provides an effective approach to correct HBB mutations without leaving any genetic footprint in patient-derived iPSCs, thereby demonstrating a critical step toward the future application of stem cell-based gene therapy to monogenic diseases.

Individuals homozygous for the C-C chemokine receptor type 5 gene with 32-bp deletions (CCR5Δ32) are resistant to HIV-1 infection. In this study, we generated induced pluripotent stem cells (iPSCs) homozygous for the naturally occurring CCR5Δ32 mutation through genome editing of wild-type iPSCs using a combination of transcription activator-like effector nucleases (TALENs) or RNA-guided clustered regularly interspaced short palindromic repeats (CRISPR)-Cas9 together with the piggyBac technology. Remarkably, TALENs or CRISPR-Cas9-mediated double-strand DNA breaks resulted in up to 100% targeting of the colonies on one allele of which biallelic targeting occurred at an average of 14% with TALENs and 33% with CRISPR. Excision of the piggyBac using transposase seamlessly reproduced exactly the naturally occurring CCR5Δ32 mutation without detectable exogenous sequences. We differentiated these modified iPSCs into monocytes/macrophages and demonstrated their resistance to HIV-1 challenge. We propose that this strategy may provide an approach toward a functional cure of HIV-1 infection.

Background Stigma is an established barrier to the provision and uptake of HIV prevention, diagnostic, and treatment services. Despite consensus on the importance of addressing stigma, there are currently no country-level summary measures to characterize stigma and track progress in reducing stigma around the globe. This data mapping exercise aimed to assess the potential for existing data to be used to summarize and track stigma, including discrimination, related to HIV status, or key population membership at the country level. Methods and findings This study assessed existing indicators of stigma related to living with HIV or belonging to 1 of 4 key populations including gay men and other men who have sex with men, sex workers, people who use drugs, and transgender persons. UNAIDS Strategic Information Department led an initial drafting of possible domains, subdomains, and indicators, and a 3-week e-consultation was held to provide feedback. From the e-consultation, 44 indicators were proposed for HIV stigma; 14 for sexual minority stigma (including sexual behavior or orientation) related to men who have sex with men; 12 for sex work stigma; 10 for drug use stigma; and 17 for gender identity stigma related to transgender persons. We conducted a global data mapping exercise to identify and describe the availability and quality of stigma data across countries with the following sources: UNAIDS National Commitments and Policies Instrument (NCPI) database; Multiple Indicator Cluster Surveys (MICS); Demographic and Health Surveys (DHS); People Living with HIV Stigma Index surveys; HIV Key Populations Data Repository; Integrated Biological and Behavioral Surveys (IBBS); and network databases. Data extraction was conducted between August and November 2020. Indicators were evaluated based on the following: if an existing data source could be identified; the number of countries for which data were available for the indicator at present and in the future; variation in the indicator across countries; and considerations of data quality or accuracy. This mapping exercise resulted in the identification of 24 HIV stigma indicators and 10 key population indicators as having potential to be used at present in the creation of valid summary measures of stigma at the country level. These indicators may allow assessment of legal, societal, and behavioral manifestations of stigma across population groups and settings. Study limitations include potential selection bias due to available data sources to the research team and other biases due to the exploratory nature of this data mapping process. Conclusions Based on the current state of data available, several indicators have the potential to characterize the level and nature of stigma affecting people living with HIV and key populations across countries and across time. This exercise revealed challenges for an empirical process reliant on existing data to determine how to weight and best combine indicators into indices. However, results for this study can be combined with participatory processes to inform summary measure development and set data collection priorities going forward., Author(s): Carrie Lyons 1,*, Victoria Bendaud 2, Christine Bourey 3, Taavi Erkkola 2, Ishwarya Ravichandran 1, Omar Syarif 4, Anne Stangl 5,6, Judy Chang 7, Laura Ferguson 8, Laura Nyblade [...]